About SUBOXONE

SUBOXONE is the first opioid medication approved under DATA 2000 for the treatment of opioid dependence in an office-based setting. SUBOXONE also can be dispensed for take-home use, just as any other medicine for other medical conditions.

The primary active ingredient in SUBOXONE is buprenorphine.

Because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin. SUBOXONE also contains naloxone, an opioid antagonist.

The naloxone in SUBOXONE is there to discourage people from dissolving the tablet and injecting it. When SUBOXONE is placed under the tongue, as directed, very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine. However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal. SUBOXONE at the appropriate dose may be used to:

Reduce illicit opioid use

Help patients stay in treatment by

Suppressing symptoms of opioid withdrawal

Decreasing cravings for opioids

History of Opioids

Opioids have been used for pleasure and for treating pain for almost 6 millennia.1,2Around 3400 BC, the Sumerians, in what is now the Middle East, referred to the opium poppy as Hul Gil or the “joy plant.”2

In 1300 BC, opioid use in Egypt spread to Greece and other parts of Europe.2 In ancient Greece, Homer wrote in The Odyssey that a daughter of Zeus served a grieving Odysseus a drink containing opium. In 460 BC, Hippocrates, the great Greek physician, used opium to treat everything from headaches and coughing to asthma and melancholy.1

Opium use disappeared from record in Europe for 200 years during the Holy Inquisition. The drug reappeared in 1527 when it was reintroduced for its medicinal properties by Paracelsus.2

Opioid abuse became prevalent during the second half of the 19th century, after the invention of the hypodermic syringe. Injecting opium allowed for a more rapid, potent effect. During the American Civil War, morphine was used to treat injuries, and opioid dependence became so common among the armed forces that it was referred to as the “soldiers’ disease.”1

In 1898, the Bayer Company began marketing a cough suppressant featuring a new ingredient called “heroin.”2

In part because it did not produce many of the side effects common to morphine, heroin was widely assumed to be nonaddictive—so much so that in the early 1900s, free samples of heroin were available by mail to recovering morphine addicts as a “step-down” cure.2

By 1914, however, heroin’s addictive properties were no longer in doubt. That year, the US government tried to curb heroin use by imposing a hefty tax on heroin. Then, in 1924, the government banned the nonmedical use of heroin, and in 1970 banned the medical use of heroin, as well.1-3

Despite the many changes in medicine over the past 6000 years, one thing that has not changed is that opioids are still regarded as highly effective, well-tolerated analgesics. Ongoing demand for pain relievers has led to the development of stronger, longer-acting medications, most of which are opioid based.

As the potency of opioid pain relievers has increased, so has patients’ risk of becoming physically or psychologically dependent on them—even when the medications are taken as directed.

In 2001, opioid dependence accounted for 18% of all substance abuse treatment admissions, exceeding cocaine admissions for the 5th consecutive year.4 At present, the number of untreated opioid-dependent patients in the United States is believed to be at least 1.2 million.5

Recognition of the urgent public health need for opioid-dependence treatment alternatives was one of the reasons SUBOXONE was developed in cooperation with the National Institute of Drug Abuse.

In 2000, Congress approved the Drug Addiction Treatment Act (DATA 2000), giving physicians the right to use approved opioids to treat opioid dependence in their offices.6 Prior to DATA 2000, this was illegal to do outside a hospital or clinic.

In October 2002, the US Food and Drug Administration (FDA) approved buprenorphine for use in treating opioid dependence.7 France approved buprenorphine for the treatment of opioid dependence in 1996, and Australia followed in 2001.8,9

Now approved in more than 30 countries, buprenorphine is marketed in the United States under the brand names SUBOXONE and SUBUTEX® (buprenorphine HCl sublingual tablets).